Single-Barrel, Double-Barrel, and Fenestrated Endografts to Facilitate Transcatheter Pulmonary Valve Replacement in Large RVOT

• Authors: Norihiko Kamioka, Emory University; Vasilis Babaliaros, Emory University; John C Lisko, Emory University; Anurag Sahu, Emory University; Subhadra Shashidharan, Emory University; Fred H Rodriguez, Emory University; Matthew R Caraza, Emory University; Maan Jokhadar, Emory University; Fred Rodriguez III, Emory University; Wendy Book, Emory University; Patrick Gleason, Emory University; William Keeling, Emory University; Wissam Jaber, Emory University; Peter Block, Emory University; Robert Lederman, Emory University; Adam Greenbaum, Emory University; Dennis Kim, Emory University
• Journal Title: JACC-CARDIOVASCULAR INTERVENTIONS
• Volume: Volume 13, Number 23
• Publisher: ELSEVIER SCIENCE INC | 2020-12-14, Pages 2755-2765
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1016/j.jcin.2020.08.024
• Subjects: Health Sciences, Medicine and Surgery
• Keywords: Science & Technology; Life Sciences & Biomedicine; Cardiac & Cardiovascular Systems; Cardiovascular System & Cardiology; fenestrated endograft; pulmonary insufficiency; pulmonary regurgitation; right ventricular outflow tract; transcatheter electrosurgery; transcatheter pulmonary valve replacement; transcoronary pacing; VENTRICULAR OUTFLOW TRACT; REPAIRED TETRALOGY; MAGNETIC-RESONANCE; HYBRID APPROACH; OUTCOMES; IMPLANTATION; REGURGITATION; FALLOT; SOCIETY; CONTEXT

Abstract

Objectives: The aim of this study was to test the hypothesis that narrowing the landing zone using commercially available endografts would enable transcatheter pulmonary valve replacement (TPVR) using commercially available transcatheter heart valves. Background: TPVR is challenging in an outsized native or patch-repaired right ventricular outflow tract (RVOT). Downsizing the RVOT for TPVR is currently possible only using investigational devices. In patients ineligible because of excessive RVOT size, TPVR landing zones were created using commercially available endografts. Methods: Consecutive patients with native or patch-repaired RVOTs and high or prohibitive surgical risk were reviewed, and this report describes the authors’ experience with endograft-facilitated TPVR (EF-TPVR) offered to patients ineligible for investigational or commercial devices. All EF-TPVR patients were surgery ineligible, with symptomatic, severe pulmonary insufficiency, enlarged RVOTs, and severe right ventricular (RV) enlargement (>150 ml/m2). TPVR and surgical pulmonary valve replacement (SPVR) were compared in patients with less severe RV enlargement. Results: Fourteen patients had large RVOTs unsuitable for conventional TPVR; 6 patients (1 surgery ineligible) received investigational devices, and 8 otherwise ineligible patients underwent compassionate EF-TPVR (n = 5 with tetralogy of Fallot). Three strategies were applied on the basis of progressively larger RVOT size: single-barrel, in situ fenestrated, and double-barrel endografts as required to anchor 1 (single-barrel and fenestrated) or 2 (double-barrel) transcatheter heart valves. All were technically successful, without procedure-related, 30-day, or in-hospital deaths. Two late complications (stent obstruction and embolization) were treated percutaneously. One patient died of ventricular tachycardia 36 days after EF-TPVR. Compared with 48 SPVRs, RV enlargement was greater, but 30-day and 1-year mortality and readmission were no different. The mean transvalvular pressure gradient was lower after EF-TPVR (3.8 ± 0.8 mm Hg vs. 10.7 ± 4.1 mm Hg; p < 0.001; 30 days). More than mild pulmonary insufficiency was equivalent in both (EF-TPVR 0.0% [n = 0 of 8] vs. SPVR 4.3% [n = 1 of 43]; p = 1.00; 30 days). Conclusions: EF-TPVR may be an alternative for patients with pulmonic insufficiency and enlarged RVOTs ineligible for other therapies.